Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Elizabeth Orr

Managing Editor, Policy & Regulation

Washington, DC

Elizabeth leads a team of Medtech Insight reporters devoted to covering medical device and diagnostics regulation in the US and abroad. As a reporter, she focuses on FDA regulation, legislation, and legal issues. A graduate of the University of Maryland College Park, she worked for outlets including FDA News, DecisionHealth (formerly UCG) and the Washington Examiner before joining Medtech Insight in 2015. She lives in Arlington, VA, with her husband and children.

Latest From Elizabeth Orr

MDSAP Audit Allows Emerging Firm To Expand Internationally

Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight

Regulation Strategy

FDA’s Power Morcellation Containment System Guidance Doc Finalized

The US FDA has finalized a guidance document that details performance assessment standards for power morcellation containment systems. The class II devices have been an object of special scrutiny since the agency learned that power morcellation could spread cancerous tissue throughout the body.

Regulation Guidance Documents

EPA Gives Stakeholders Additional 15 Days For EtO Comments

The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June. 

Policy Safety

‘Wait-and-See Time’: Panel Predicts Limited Congressional Action On Devices This Year

An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.  

Legislation Policy

News We’re Watching: Premom Data Privacy Settlement, Labcorp Owes $372m For Patent Violations, Elixir Stent Trial Success

This week, the DC Attorney General announced a settlement with ovulation-tracking app Premom; a novel scoliosis treatment won FDA approval; research showed Fractyl Health’s Rejuva delivery system can deliver gene therapy directly to the pancreas; and BearCare recalled a thermometer over burn risks.

Commercial Regulation

Shuren: ‘You Can’t Be Expecting Us To Just Sit Back’

In a wide-ranging speech at FDLI’s 2023 annual meeting, CDRH director Jeffrey Shuren pledged to move forward with regulatory action on lab-developed tests and sketched plans for improved regulation of medical apps.

Policy Review Pathway
See All
UsernamePublicRestriction

Register